FDA Adverse Event
Injury
Summary report: N
RASCAL
MDR report key: 509237
·
Received February 3, 2004
Report
- Report Number
- 2246975-2004-00007
- Event Type
- Injury
- Date Received
- February 3, 2004
- Date of Event
- January 3, 2004
- Report Date
- January 5, 2004
- Manufacturer
- ELECTRIC MOBILITY CORP.
- Product Code
- ITI
- Removal / Correction Number
- 2246975.2002.002.C
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
DESCRIBE EVENT OR PROBLEM: WHEEL HUB CRACKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RASCAL | VEHICLE, 4-WHEEL MOTORIZED | ITI | ELECTRIC MOBILITY CORP. | 305 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |